Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit
2013 Archived Content

Second Annual | June 5-6, 2013
Clinical Quality Risk Management

Implementing a Comprehensive Quality Management System for Good Clinical Practice

Focused on meeting the emerging regulatory expectations for a quality systems-based approach to GCP compliance, the Clinical Quality Risk Management track will feature thought leaders’ experiences implementing clinical QRM, creating quality systems-based approaches to clinical monitoring and auditing and responding to the evolving landscape within both the FDA and international regulatory bodies. Throughout the conference, quality management systems and the lessons learned during the implementation of those systems will be addressed, as well as the effect of quality risk management on individual clinical roles. Practical applications and takeaway QRM tools will be provided. Attendees can expect to hear case studies regarding the implementation of clinical QRM and Quality by Design, creating a quality systems-based approach to clinical monitoring and auditing that produces reliable data and responding to the evolving regulatory landscape. The conference will feature case studies, take-away tools, perspectives on the current regulatory environment, breakout groups and interactive activities.

Day 1 | Day 2 | Download Brochure 

Wednesday, June 5, 2013

7:00am Registration and Morning Coffee

8:00 Barnett Welcome & Chairperson’s Opening Remarks

8:15 Case for Change: Business Case for QRM

Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC

QRM is a quality management system which helps to improve a company’s methods of working in ensuring high quality results and compliance with regulations and internal processes in the conduct of clinical trials, pharmacovigilance, and other functions. Implementing a quality management system has wide-spread applicability within an organization. The fundamental question most organizations ask when pursuing such an approach is “Where do I start?” In order to deliver the message of value for an organization, focus resources on the areas of highest risk – to gain access to required resources and to acquire the needed support for such an initiative in general – is first to build a business case that will serve as a benefit/cost analysis to justify the investment of QRM and the changes it will bring with it.

9:00 An Innovative, Automated Approach to Effective Risk Management in Clinical Development

Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis

This session will explore TAPAS© (Trend and Pattern Alert System), the basis of Novartis’ quality risk management (QRM) program. As the risk management approach will receive data almost in real-time, it is possible to monitor and assess risks on an ongoing basis or at appropriate intervals. If a problem is detected, the system can notify the business stakeholder, who can then work to identify any necessary mitigating actions. Over time, the assessment results accumulate and it becomes possible to calculate trend analyses across particular risk indicators and entities. The tool is powered by data that are collected routinely anyway on trial and site performance, and in support of trial analysis.

9:45 Networking Coffee Break and Exhibit Viewing

10:15 Adapting the Risk Quality Management Approach to Clinical Research

Shirley Roach, Regulatory PM, Quality, Allied Technologies and Consulting

You cannot improve what you cannot measure. Developing metrics to measure results and allow for continual quality improvement. Quality risk management tools have not been adapted to clinical research but could have a role in standardized quality practices. We perform global research and we have to ensure results posted in Timbuktu mean the same as those posted from Topeka... we have to have a baseline for quality and build from there.

11:00 Interactive Roundtable Discussions

11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00pm Quality by Design: How to Identify Pitfalls and Showstoppers in Advance when Planning Your Trial

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

Planning, conducting, and reporting on clinical trials today is becoming increasingly complex. This results in many different problems, such as cost of clinical development and limitation of resources, globalization of trials with complex regulatory, business and scientific environments, risk aversion with little appreciation of risks or what risks actually are, over-interpretation of the regulatory environment, poor design of studies, failure to identify priorities, and lack of proportionality in the implementation of QC activities. In order to overcome these and other issues, a Quality by Design approach must be applied from the very beginning when planning your clinical programs. With QbD, you will know in advance what the key aspects or your particular trial are and how to stay in control to deliver a successful study.


Quality Risk Management (QRM) at site level requires development of well defined and relevant metrics, Key performance and quality indicators (KP-QI), as well as a solid process for review and follow-up of the identified signals. Both aspects need to be supported by robust information management as well as training and cross-functional communication strategies.

Part 1 

1:45 Practical Aspects of Developing Relevant Key Performance and Quality Indicators (KP-QIs)

Sina Djali, Director, Quality Monitoring and Compliance/Quality Systems, Janssen

In this presentation we focus on practical aspects of developing relevant KP-QIs. These include both subject level and operational data required to implement a robust internal QRM system. We will also focus on some of the integration and information management aspects of QRM.

Part 2 

2:30 Processes in Support of a Risk-Based Approach in Managing Site-Level Compliance

Sean P. Murphy, MS, Associate Director, Global Trial Manager, Janssen R&D

In this presentation we will focus on implementing processes in support of a risk-based approach in managing investigator site level compliance. These will include processes for review of information tailored to the different stages of a trial (initiation vs. execution). We will also discuss the role of a central vs. on site monitoring teams and provide a model on interaction between both in the follow-up of identified signals.


3:15 Sponsored Presentation (Opportunity Available)

3:30 Networking Refreshment Break and Exhibit Viewing


3:50 Fitting Actual Risk Management Principals into the FDA’s New Risk-Based Monitoring Guidance

Lee Truax-Bellows, President, Clinical, NCRA

Risk management has morphed from the good manufacturing arena to clinical study operation activities. It has become the standard not only in the US but also the EU and is receiving more attention on a world-wide basis. Besides being a new expectation by regulatory agencies under good clinical practices, it also is good business practice. To implement, one must first understand and then put such principals into practice. This proposal will provide the participant with some initial knowledge to allow a successful implementation of risk-management under the clinical umbrella.

4:35 Integration of Quality Risk Management and Risk-Based/Adaptive Monitoring

Stephannie Perrin, Associate Director, Quality Risk Management, Global Quality and Compliance, PPD

As the industry utilization of risk-based monitoring continues to increase along with the development and expansion of the area of QRM, the need for the integration of these two concepts becomes apparent. The premise behind RBM is that monitoring quality can improve by leveraging existing data intelligence. This, in turn, allows for more focused and efficient resource utilization and allocation. QRM is the proactive identification and mitigation of risks. By combining these two concepts, the inherent risks identified up front can feed into the design of the risk-based monitoring plan (Quality by Design). Other QRM tools, such as metrics dashboards, can then be used to capture emerging risks and adapt monitoring plans accordingly. The QRM tools used can help to define “must haves” in a RBM plan and can allow for better resource planning. The integration of these two evolving concepts is key to the success of both models and to streamlining processes within the industry as a whole.

5:20 Reception and Exhibit Viewing (Sponsorship Opportunity Available)

5:45 Short Course Registration

6:00 - 8:30 Dinner Short Course 2, Quality-Systems Based Approaches to a GCP Auditing Program 

6:20 Close of Day One

Day 1 | Day 2 | Download Brochure